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510(k) K041352

Device
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
Applicant
BIOMET, INC.
510(k) number
K041352
Product code
KRO  
Decision
Substantially Equivalent (SESE)
Decision date
2004-07-30
Date received
2004-05-20
Regulation
888.3510
Classification name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GARY BAKER
Address
56 E. Bell Dr. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-12-15
K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation2025-08-22
K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-07-25
K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC2024-11-21
K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.2024-04-01
K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC2024-03-21
K230563EVOLUTION® Hinge Knee SystemMicroport Orthopedics, Inc.2023-09-27
K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker2023-05-19
K223069Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21
K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-20
K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG2022-05-03
K211677ELEOS Limb Salvage SystemOnkos Surgical2021-07-28
K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG2021-06-30
K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.2021-03-02
K192798Zimmer Segmental SystemZimmer, Inc.2020-12-10

Legacy Summary#

summary

FDA Review#

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